Tranexamic Acid in Pediatric Undergoing Proximal Femoral Osteotomies and/or Acetabular Osteotomy

Not Applicable

Recruiting

• Conditions: Intraoperative Blood Loss; Pediatric; Orthopedic Disorder
• Interventions: Other: Placebo; Drug: Tranexamic acid; Procedure: caudal epidural block

• Registration Number: NCT04811313
• Lead Sponsor: Assiut University

Brief Summary

Surgical hip reconstruction reduces the hip joint through soft tissue releases and osteotomies of the femur and/or pelvis. Blood loss and subsequent blood transfusion are normal consequences of hip reconstruction.

Detailed Description

the use of antifibrinolytics (AFs) to limit blood loss peri-operatively has been popularized in certain subspecialties. AFs have been studied extensively in adults undergoing various orthopedic procedures including spine and total joint arthroplasty, and have been proven to reduce blood loss and reduce the risk of blood transfusion. Similarly, AFs are used in pediatric patients undergoing cardiac surgery as well as craniofacial operations. Tranexamic acid (TXA) is a synthetic anti-fibrinolytic agent that works by reversibly blocking plasminogen and thereby promoting hemostasis through the prevention of fibrin degradation. Current literature investigating the safety and effectiveness of TXA in children undergoing orthopedic procedures is limited.

We hypothesize that patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA.

Study Timeline

• Study First Submitted: 2021-03-19
• Study First Submitted QC: 2021-03-19
• Study First Posted: 2021-03-23
• Status Verified: 2025-04
• Study Start: 2025-04-03
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-10
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• ASA I - II
• Scheduled for acetabular osteotomy and/or proximal femoral derotation osteotomies.

Exclusion Criteria

• Patient's guardian refusal to participate in the study.
• Children known to have pre-existing bleeding or coagulation disorders.
• Children with anemia; defined according to (WHO ) cutoffs as Hb level<11g/dl for girls and <12g/dl for boys
• History of epilepsy.
• History of renal insufficiency or failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
P group	Placebo	participants will receive the regular standard care without adding tranexamic acid or caudal epidural block
TC group	caudal epidural block	each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
C group	caudal epidural block	each participant will receive a caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
TC group	Tranexamic acid	each participant will receive 10 mg/kg of tranexamic acid diluted in a 5 mL syringe slowly over 5 minutes, 15 minutes before skin incision, and A caudal epidural block with 1 mL/kg of 0.25% bupivacaine.
T group	Tranexamic acid	each participant will receive 15 mg/kg of tranexamic acid diluted in a 10 mL syringe slowly over 10-15 minutes, 15 minutes before skin incision.

Primary Outcome Measures

Name	Time	Method
amount of intraoperative blood loss	24 hours	calculated from the fall in red blood cell volume

Secondary Outcome Measures

Name	Time	Method
Rate of blood transfusion	24 hours	either intraoperative or postoperative blood transfusion
length of hospital stay	24 hours	readiness for hospital discharge
Incidence of adverse effects or complications of TXA	24 hours	e.g. thromboembolic events or perioperative seizures will be managed and recorded

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt